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Pregnancy Hormone Shows Promise as Heart Failure Drug

Pregnancy Hormone Shows Promise as Heart Failure Drug

WEDNESDAY, Nov. 7 (HealthDay News) -- A synthetic form of a
hormone that ramps up during pregnancy might prove to be a powerful
new drug against tough-to-treat heart failure.

Researchers who presented data from a study this week at the
American Heart Association annual meeting in Los Angeles said the
drug, serelaxin, shows promise.

But experts were cautious, saying the findings need to be
repeated in larger trials.

"If we did replicate this finding, it would be an extraordinary advance in the care of acute heart failure, for which we have no disease-modifying or life-saving therapies," said Dr. John McMurray, professor of cardiology at the University of Glasgow, in Scotland, who commented on the study during an AHA press briefing.

Serelaxin is the lab-created version of a natural hormone in men
and women called human relaxin 2. Relaxin circulates in low levels
in humans, but spikes dramatically in women during pregnancy.

As study author Dr. John Teerlink explained at the briefing,
"pregnancy is a physiologic state where there are marked
improvements in cardiac, arterial and [kidney] function, and these
are exactly the kinds of changes that we'd like to see in acute
heart failure."

In humans, relaxin also has been shown to improve blood flow and
cut down on inflammation, so scientists thought it might help fight
heart failure.

In heart failure, the heart is damaged (often by a heart attack)
and becomes inefficient, leading to chronic weakness and shortness
of breath. The condition is often fatal, and there has been no real
advance in treating the disease for decades.

In the study, Teerlink and his colleagues randomly assigned more
than 1,600 hospitalized heart failure patients with an average age
of 72 to receive either 30 micrograms per day of serelaxin or a
placebo via a 48-hour infusion.

Patients received the medication within 16 hours of their
hospitalization due to shortness of breath plus a drop in kidney
function. They also were given standard diuretics to help remove
excess liquid from the body and to ease swelling.

Three-quarters of the patients in the study were men, and they
tended to be very sick, with multiple conditions such as high blood
pressure, high cholesterol, heart disease, diabetes and prior
stroke.

Serelaxin did seem to have a benefit, with shortness of breath
easing by 20 percent on average, Teerlink said. The team found that
patients on the medication also had 43 percent fewer episodes of
heart failure symptoms while in the hospital, they cut short their
stay in the ICU by half a day on average and their total hospital
stay was cut by a full day on average, compared to patients taking
the placebo.

Over the longer term, the researchers reported, patients taking
serelaxin were 37 percent less likely to die from any cause
(including heart disease) six months after beginning treatment,
compared to those on placebo.

There was one unusual finding, however: Use of the drug did
notcut down on rehospitalizations, nor did it cut down on
deaths from heart failure specifically.

McMurray said that finding has made him a little cautious in his
response to the study. "It's very unusual to see a treatment in
heart failure that can improve survival but not reduce
rehospitalization," he said.

The drug's safety profile seemed fine, however. "Serelaxin was
well-tolerated and safe, with no differences in adverse events or
serious adverse events" between the treated and placebo groups,
said Teerlink, who is a professor of medicine at the University of
California, San Francisco.

The study was funded by drug company Corthera Inc.

The need for a new, effective treatment for heart failure is so
dire that experts said they would immediately prescribe serelaxin
for their patients -- if the findings from this trial are
replicated and the drug is approved.

"If this drug reduces mortality -- if that mortality finding is real -- boy, are we going to get excited," said Dr. Elliott Antman, a cardiologist at Brigham and Women's Hospital, in Boston. "The real question is whether the mortality difference seen in this trial is a true and replicable finding."

But another expert noted that initial trials of promising new
medicines for heart failure have raised false hopes in the
past.

Dr. Mariell Jessup is medical director of the Penn Medicine
Heart and Vascular Center at the University of Pennsylvania
Perelman School of Medicine, in Philadelphia, and president-elect
of the American Heart Association.

"We have very little that we can use in the hospital" for heart failure, Jessup said, so the advent of a drug like serelaxin "would be an exciting find."

"But I also agree with the caveats that we've heard -- that it's a small trial and maybe we've been misled," she added.

Experts also stress that findings presented at medical meetings
are typically considered preliminary until published in a
peer-reviewed journal.

Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.